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Anatomical Pathology Tissue Release Policy

We recognise the importance of all pathology and forensic samples entrusted to our care. Our Anatomical Pathology (AP) Tissue Release Policy outlines our commitment to the highest ethical standards and rigorous regulatory compliance.

The policy establishes a standardised and transparent statewide approach to the release of AP tissue.

This ensures fair and responsible service to our patients, clinicians, research partners and other stakeholders.

Overview

Our work goes beyond clinical testing to support patient diagnoses, treatment and care.

We are sometimes asked to release samples for secondary purposes such as research or court matters.

The policy outlines procedures and considerations for this to ensure any release is ethically sound and meets formal requirements.

What the policy covers

The policy informs the release of AP tissue for:

  1. Research - clinical trials, studies, biobank storage and more.
  2. Ongoing patient care - seamless care and management of patients relocating interstate or overseas to maintain continuous medical history.
  3. Second opinions - empowering patients to seek second opinions and make healthcare decisions.
  4. Quality assurance and improvement - quality control, audits and training that help deliver quality healthcare.
  5. Legal compliance - responding to subpoenas or court orders while ensuring the privacy and confidentiality of patient information.
  6. Care of individuals other than the original patient.
  7. Patient disposal requests - managing patient requests to return AP tissue for disposal.
Our Commitment

The policy reflects our dedication to transparency and responsible stewardship of pathology and forensic samples.

Our Commitment

The policy reflects our dedication to transparency and responsible stewardship of pathology and forensic samples.

Learn More

AP Tissue Release Policy fact sheet

AP Tissue Release Policy

Informed Patient Consent Form

 

We invite you to join one of our virtual sessions to learn more. NSWHP’s Prof. Wendy Cooper and A/Prof. Elizabeth Salisbury will share more about what this means for you, our research partners and patients, and answer your questions.

Join one of our online sessions. Click the date or scan the QR codes to save it to your calendar.

Need help?

If you have a question about the policy, please contact our Anatomical Pathology Clinical Stream lead.

Questions about research can be directed to our Research Services Team.

Have a question?

Find answers to your questions about the NSW Health Pathology (NSWHP) Anatomical Pathology (AP) Tissue Release policy.

A policy ensuring a standardised, statewide approach to the release of Anatomical Pathology (AP) tissue by NSW Health Pathology for purposes beyond clinical diagnostic assessment including research, legal requirements and second opinions.

The policy ensures the release of any tissue is ethically sound and meets regulatory, policy and accreditation requirements and standards.

Patients and families can be assured that all AP tissue requests are managed safely and ethically according to the latest accreditation standards and guidelines.

A working group of pathologists, researchers, legal representatives and more, in consultation with our Anatomical Pathology Clinical Stream and Research Advisory Committee.

Human tissue received and used by our AP laboratories for primary diagnostic purposes. This includes tissue from surgical resections, biopsies and cytology procedures, and that retained in slides, formalin-fixed paraffin-embedded (FFPE) blocks etc. It does not include tissue from autopsies.

Tissue removed during autopsies or taken for purposes other than primary diagnostic care, e.g. solely for research.

We strongly favour retaining original slides and at least 1 original diagnostic block per patient episode to ensure enough material for future testing as part of clinical treatment, and to ensure we meet pathology accreditation standards.

If more than 1 block is available, we will consider block release, recut slides and/or scrolls.

We prefer to supply recut slides and/or scrolls. If these are insufficient for a purpose that directly informs the patient’s treatment (e.g. a clinical trial they’re enrolled in), we will only release the block with specific, informed patient consent that explains the implications for their testing needs.

We won’t release the block if the request doesn’t inform patient treatment.

We don’t generally release original slides except where necessary for the ongoing care and treatment of the patient whose tissue it is. If more than 1 block is available, we will consider block release, recut slides and/or scrolls.

The requesting party is responsible for immediate deidentification of blocks, slides or scrolls on receipt.

Study ethics require samples to be able to be reidentified and notified back to treatment teams if a clinically significant finding is made that has critical implications for a patient.

Identifiable information must be retained on all blocks and original diagnostic slides. It can be covered to protect patient confidentiality but it cannot be removed. Coverings must be able to be removed without damaging original labels.

Reidentification for quality control projects or assay development is not required as this work has no implications for patients or clinical teams.

Yes provided the patient has consented to the overseas transfer and purpose, and that this and intention for overseas transfer is included in the Material Transfer Agreement (MTA).

Recipient agencies must operate with equivalent protections and privacy safeguards.

Recipients must return material in a timely manner unless alternative arrangements have been agreed by NSWHP (e.g. a patient is relocating permanently overseas).

Such specimens are not covered by this policy. This would require patient consent and incur a processing charge as per our Research Services Statewide Price Guide.

No. All access requests for tissue or other NSWHP research services continue to be submitted via eResearchWithUs. NSWHP researchers need to generate a Site Specific Agreement (SSA) in REGIS and list NSW Health Pathology as the site.

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